2026-09-21 · Equipo editorial KeXinMaterials

PED 2014/68/UE + UKCA Directiva Equipos a Presión Deep Dive + Marcado CE + Organismo Notificado + B2B Guía

PED 2014/68/UE "Directiva Equipos a Presión" es la directiva UE para equipos a presión. Reemplaza PED 97/23/CE. Marcado CE + UKCA + Organismo Notificado + UK Approved Body requeridos.

PED 2014/68/EU Scope + Categories

PED 2014/68/EU applies to pressure equipment + assemblies with PS > 0.5 bar. Categories I-IV based on fluid + state + P×V + DN.

PED 2014/68/EU: "Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment". Replaces PED 97/23/EC. Effective 19 July 2016. Mandatory.

Scope: Design + manufacture + conformity assessment of pressure equipment + assemblies placed on EU market. Maximum allowable pressure PS > 0.5 bar (gauge).

Pressure equipment scope: Vessels (storage + process) + piping (interconnecting + distributing) + safety accessories (devices to prevent safe limits) + pressure accessories (devices with safety function relying on pressure) + assemblies (multiple pieces of pressure equipment assembled by manufacturer).

Excluded from PED per Article 1 § 2: Pipelines for distribution of gas + heat + water + public + industrial use. Equipment covered by other EU directives: Simple Pressure Vessels Directive (SPVD) 2014/29/EU + Transportable Pressure Equipment Directive (TPED) 2010/35/EU + Aerosol Dispensers Directive (ADD) 75/324/EEC + Machinery Directive 2006/42/EC + ATEX 2014/34/EU (where primary risk is explosion) + Pressure Equipment for use on ships + aircraft.

Fluid Group 1 per PED Article 13: Explosive + extremely flammable + highly flammable + flammable + very toxic + toxic + oxidizing. Examples: hydrogen + methane + propane + ethylene + acetylene + chlorine + ammonia + oxygen.

Fluid Group 2 per PED Article 13: All other fluids not in Group 1. Examples: water + steam + air + nitrogen + argon + hydraulic oil + lubricating oil + refrigerants.

Fluid State per PED: Gaseous + liquefied + dissolved + liquid. Different requirements per state.

PED Category I: Lowest hazard. Stable gas with PS × V <= 1000 bar·L. Unstable gas with PS <= 10 bar. Non-hazardous liquid with PS × V <= 5000 bar·L.

PED Category II: Medium-low hazard. Stable gas with PS × V <= 3000 bar·L. Non-hazardous liquid with PS × V <= 50000 bar·L. Hazardous liquid with PS × V <= 3000 bar·L.

PED Category III: Medium-high hazard. Stable gas with PS × V <= 15000 bar·L. Hazardous gas with PS × V <= 10000 bar·L. Non-hazardous liquid with PS × V > 50000 bar·L. Hazardous liquid with PS × V <= 15000 bar·L.

PED Category IV: Highest hazard. Stable gas with PS × V > 15000 bar·L. Hazardous gas with PS × V > 10000 bar·L. Hazardous liquid with PS × V > 15000 bar·L. Unstable gas with PS > 10 bar.

Category determination per PED Annex II Tables 1-9: Combinations of fluid group + state + pressure + volume + DN. Different table per combination.

DN (Nominal Diameter) per PED: Used for some categories. Standardized pipe + fitting + valve sizing per ISO 6708. DN 15 = 1/2" + DN 25 = 1" + DN 50 = 2" + DN 100 = 4" etc.

Geographic adoption: EU + EEA + Switzerland + UKCA (UK equivalent).

B2B relevance: For B2B protective cases containing pressure equipment for EU + UK market, PED 2014/68/EU compliance + UKCA + CE marking + Notified Body + Conformity Assessment Module is procurement requirement.

Conformity Assessment Modules + Notified Body

Conformity assessment modules A + A2 + B + C + C1 + C2 + D + D1 + E + E1 + F + G + H + H1 per PED Annex III.

Conformity Assessment Modules per PED Annex III: Modules A (Internal production control) + A2 (Internal production control + supervised product tests) + B (EU-type examination) + C (Production conformity based on internal production control) + C1 (Production conformity based on internal production control + supervised product tests) + C2 (Production conformity based on internal production control + supervised product tests at irregular intervals) + D (Production quality assurance) + D1 (Production quality assurance with monitoring of final assessment) + E (Product quality assurance) + E1 (Product quality assurance with final product inspection + testing) + F (Product verification) + G (Unit verification) + H (Full quality assurance) + H1 (Full quality assurance with design review + special surveillance of final assessment).

Module A: Internal production control. Self-declaration. No Notified Body involvement. For low-hazard equipment (Category I typically).

Module A2: Internal production control + supervised product tests. Self-declaration + Notified Body surveillance testing. For Category II typically.

Module B: EU-type examination. Notified Body examines design + type. Notified Body issues EU-Type Examination Certificate. Combined with Module C/D/E/F for production conformity.

Module C: Production conformity based on internal production control. Self-declaration of production conformity per type (after Module B). For Category II typically.

Module D: Production quality assurance. Notified Body audits + approves production QMS per EN ISO 9001 + PED-specific. Approves + certifies production process. For Category III typically.

Module D1: Production quality assurance with monitoring of final assessment. Module D + final assessment monitoring by Notified Body.

Module E: Product quality assurance. Notified Body audits + approves product quality assurance. For Category III typically.

Module E1: Product quality assurance with final product inspection + testing. Module E + final product inspection by Notified Body.

Module F: Product verification. Notified Body verifies each product or batch. For Category III typically.

Module G: Unit verification. Notified Body verifies each individual product. For Category IV typically.

Module H: Full quality assurance. Notified Body audits + approves full quality assurance system (design + production + final assessment + traceability). For Category III + IV typically.

Module H1: Full quality assurance with design review + special surveillance of final assessment. Module H + design review + final assessment monitoring. For highest-hazard equipment.

Module selection per PED: Per Annex III. Different modules allowed per Category. Per Category I typically Module A. Category II typically A2 or D1 or E1. Category III typically B+D / B+F / B+E / H. Category IV typically B+D / B+F / G / H.

Notified Body per PED: EU Notified Body designated by Member State + listed on NANDO (New Approach Notified and Designated Organisations) database. Examples: TUV SUD + TUV NORD + TUV Rheinland + DNV + LRQA + Bureau Veritas + SGS + Intertek + BSI + DEKRA + Applus + Centre Testing International (CTI).

Notified Body scope: Each Notified Body has specific scope per directive + module + equipment type. Verify scope before engagement.

Notified Body number: 4-digit identification number per Notified Body. Must be on CE mark + EU Declaration of Conformity.

EU Declaration of Conformity (DoC): Required for all pressure equipment with CE marking. Manufacturer declares compliance with all applicable directives + harmonized standards + essential requirements + Notified Body (where applicable).

Technical File per PED: Required for all pressure equipment. Includes design + manufacturing + test + calculation + risk assessment + operating instructions + drawings + specifications + materials.

Operating instructions per PED Annex I § 3.6: Required for all pressure equipment. Manufacturer + identification + conditions of use + safe use + warnings.

Marking per PED Annex I § 3.3: CE mark + identification of manufacturer + year of manufacture + serial / batch number + max allowable pressure + max allowable temperature + min allowable temperature + fluid type.

Common B2B mistakes: (1) Missing CE marking. (2) Missing Notified Body involvement for high-hazard equipment. (3) Missing EU Declaration of Conformity. (4) Missing Technical File. (5) Missing operating instructions. (6) Missing UKCA for UK market.

B2B recommendation: For B2B pressure equipment case for EU market, require PED 2014/68/EU compliance + Category determination + Conformity Assessment Module selection + Notified Body (where required) + CE marking + EU DoC + Technical File + operating instructions + marking.

UKCA + CE Marking + EU + UK + Global Market Entry

UKCA marking post-Brexit for UK market. CE marking for EU market. Global market entry strategy for pressure equipment.

UKCA (United Kingdom Conformity Assessed): UK marking post-Brexit. Effective 1 January 2021. Required for pressure equipment placed on UK market (England + Wales + Scotland). UKCA replaces CE marking for UK market. Northern Ireland follows EU CE marking under Windsor Framework.

UKCA marking per UK Pressure Equipment (Safety) Regulations 2016: Implements PED 2014/68/EU in UK law. Categories I-IV per PED. UK Approved Body required for high-hazard equipment.

UK Approved Body: UK designation per UK Accreditation Service (UKAS) + UK regulations. Examples: BSI Group (UK) + Lloyd Register (UK) + SGS UK + TUV SUD UK + TUV NORD UK + UL VS Ltd (UK) + DEKRA UK.

UKCA vs CE marking: CE marking accepted in UK for some product categories until 31 December 2024 for most categories. After that, UKCA required for UK market. Some categories (medical + construction + transport) have extended transition.

UKCA marking content: UKCA mark + identification of manufacturer + year of manufacture + approved body number (where required) + serial / batch number + max allowable pressure + max allowable temperature.

Windsor Framework (EU-UK 2023): Northern Ireland follows EU CE marking for goods placed on NI market. Rest of UK follows UKCA.

Dual CE + UKCA marking: Required for global market access. Common for pressure equipment manufacturers selling in EU + UK + rest of world.

CE marking globally: Acceptable in many countries outside EU + EEA. Mutual Recognition Agreements (MRAs) with various countries.

PED + global equivalent: ASME BPVC (US + Canada + global) + PED (EU + UK) + GB 150 (China) + SH/T 3053 (China petrochem) + High Pressure Gas Safety Act (Japan) + SANS 347 (South Africa) + TDG Regulations (Canada transportable).

ISO 16528-1 (2022) + ISO 16528-2 (2022): Boiler and Pressure Vessel standards. International ISO standards for pressure vessels + boilers.

ADR 2023 (European Agreement concerning the International Carriage of Dangerous Goods by Road): For transportable pressure equipment + cylinders + pressure drums.

RID 2023 (Regulations concerning the International Carriage of Dangerous Goods by Rail): For rail transportable pressure equipment.

ADN 2023 (European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways): For inland waterway transportable pressure equipment.

IMDG Code (International Maritime Dangerous Goods Code): For maritime transportable pressure equipment.

IATA DGR (Dangerous Goods Regulations): For air transportable pressure equipment.

UN Recommendations on the Transport of Dangerous Goods (UN RTDG): Model regulations. Basis for ADR + RID + ADN + IMDG + IATA DGR.

TPED 2010/35/EU (Transportable Pressure Equipment Directive): EU directive for transportable pressure equipment (gas cylinders + drums + tubes). Conformity assessment + Notified Body + CE marking + Pi marking.

Pi marking per TPED: Marking for transportable pressure equipment. Pi + identification of manufacturer + identification of Notified Body + year + serial + pressure + temperature + fluid.

Common B2B mistakes: (1) Missing UKCA for UK market. (2) Missing CE marking for EU market. (3) Missing Notified Body for high-hazard. (4) Missing TPED for transportable. (5) Missing transport regulations (ADR + RID + IMDG + IATA) for transportable.

B2B recommendation: For B2B pressure equipment case for global market, require PED CE marking (EU) + UKCA (UK) + ASME Stamp (US + global) + TPED (transportable) + ADR + RID + IMDG + IATA + Notified Body / Approved Body + CE + UKCA + Technical File.

B2B Procurement Workflow + Cost + Test Lab + Case Design

PED + UKCA B2B procurement workflow + cost + test lab + protective case requirements for EU + UK market.

B2B procurement workflow: (1) Identify pressure equipment + market (EU + UK + global). (2) Determine PED Category I-IV + Conformity Assessment Module. (3) Identify Notified Body + UK Approved Body (where required). (4) Verify material certificates + traceability. (5) Verify welding per ASME IX / EN ISO 15614 + NDE per EN ISO 17637 + EN ISO 17636 + EN ISO 17640. (6) Verify hydrostatic test per ASME VIII UG-99 / PED Annex I. (7) Verify CE marking + UKCA marking + EU Declaration of Conformity + Technical File. (8) Verify operating instructions + marking.

PED cost: PED CE marking EUR 20-80K depending on Category + Module. Notified Body cost EUR 10-50K depending on Module. Hydrostatic test EUR 5-15K per vessel. Welding qualification EUR 10-30K. Total EUR 50-150K for typical CE marking + Module H + EU Declaration of Conformity.

UKCA cost: Similar to PED + UK Approved Body cost EUR 15-50K. Total EUR 50-150K for UKCA + Module H.

Duration: PED CE marking 3-9 months. UKCA 3-6 months. Notified Body audits 6-12 weeks. Total 6-12 months for full compliance.

Test lab: Notified Body + UK Approved Body = TUV SUD + TUV NORD + TUV Rheinland + DNV + LRQA + Bureau Veritas + SGS + Intertek + BSI + DEKRA + Applus + CTI. All accredited for PED + UKCA.

NDE per EN ISO 17637 + 17636 + 17640: Radiography + ultrasonic + magnetic particle + liquid penetrant + eddy current + visual. Mandatory for welded pressure equipment per PED.

Welding per EN ISO 15614-1 + EN ISO 15613 + EN ISO 9606-1 + EN ISO 14731: Procedure qualification + Welder performance qualification + Testing. Mandatory for welded pressure equipment per PED.

Material certificates per EN 10204: Type 2.1 (Declaration of compliance) + Type 2.2 (Test report) + Type 3.1 (Inspection certificate from manufacturer independent of production) + Type 3.2 (Inspection certificate from independent third party). For PED typically Type 3.1 or 3.2.

Common B2B mistakes: (1) Missing PED Category determination. (2) Missing Module selection. (3) Missing Notified Body for high-hazard. (4) Missing UKCA for UK. (5) Missing material certificates per EN 10204. (6) Missing welding qualification per EN ISO 15614. (7) Missing NDE per EN ISO 17637. (8) Missing hydrostatic test per ASME VIII UG-99.

Protective case requirements for pressure equipment: (1) PED compliance for EU + UKCA for UK. (2) CE marking accessibility + UKCA marking accessibility. (3) Pressure relief device accessibility per PED Annex I § 2.10. (4) Marking + nameplate per PED Annex I § 3.3 + 3.4. (5) Material certificates + traceability documentation in case. (6) Operating instructions in case. (7) Inspection openings per PED Annex I § 3.7. (8) Chemical-resistant case material for hydrocarbon exposure.

Common applications: Pressure regulators + gas cylinders + pressure gauges + safety valves + pressure switches + pressure transmitters + heat exchangers + pressure vessels + filters + valves + pumps.

EU + UK market entry: CE + UKCA + Declaration of Conformity + Technical File + Notified Body / UK Approved Body for high-hazard equipment.

Common B2B documentation requirements: (1) EU Declaration of Conformity. (2) UK Declaration of Conformity. (3) PED Module selection + Conformity Assessment. (4) Material certificates per EN 10204. (5) Welding procedure + welder qualification per EN ISO 15614 + EN ISO 9606. (6) NDE records per EN ISO 17637. (7) Hydrostatic test report. (8) Marking + nameplate + operating instructions.

B2B recommendation: For B2B pressure equipment case for EU + UK + global, require PED CE + UKCA + ASME Stamp + TPED (if transportable) + ADR + RID + IMDG + IATA + Notified Body + UK Approved Body + EN 10204 material certificates + EN ISO 15614 welding + EN ISO 17637 NDE + ASME VIII UG-99 hydrostatic test + operating instructions + marking.

Preguntas frecuentes

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